Record number of new biopharmaceutical drugs receive FDA approval in 2009, most outside US

By Emily Nichols / January 18, 2010

Home / Blog / Record number of new biopharmaceutical drugs receive FDA approval in 2009, most outside US

2009 saw considerably more full FDA approvals (BLAs, NDAs) for biopharmaceuticals products, with 19 (16 if you remove the 3 that were not all that new) compared to 11 and 10 approved in 2008 and 2007, respectively (so says the Biotechnology Information Institute).

According to the BII, a record number of products were approved for orphan indications, yet no biopharmaceuticals received approval for cancer indications. It’s only a matter of time, since cancer has a strong trial pipeline.

The full list of approved drugs, with an analysis, is available on their web site.

The study points out that only five approvals originated at US-based companies. This number decreased from seven in 2008. Johnson and Johnson (New Brunswick, NJ) and Genzyme (Cambridge, MA) were among the lucky few US companies to have products approved in 2009. The record number of FDA approvals is mainly grounds for celebration in Europe.

Pharmatech Talk does a nice job articulating some of the possible reasons for this trend, and it’s impact.

When you have clinical research and development questions, the answer is Clearly Clinipace.

At Clinipace, a global, full-service contract research organization (CRO), our approach to clinical research is personal. We deliver a level of collaboration and flexibility not possible in a traditional CRO environment. With personalized services and solutions, local regulatory expertise and therapeutic leadership, we overcome the most difficult industry challenges across all major therapeutic areas including oncology, gastroenterology, and nephrology and urology. We strive to improve the way clinical research is performed and impact the future of health care using the most advanced technology and a CHALLENGE ACCEPTED approach.